Digene Corporation and Asuragen, Inc., a newly formed molecular diagnostic company and formerly a division of Ambion, Inc., have entered into an exclusive, worldwide agreement for the marketing and distribution of Asuragen's cystic fibrosis (CF) screening products. Digene has made an up-front payment to Asuragen and will make additional payments based on regulatory milestones. Additional financial details of the agreement were not disclosed.

Under the agreement, Digene will have the exclusive rights to market and distribute Asuragen's Signature CF products world-wide. In addition, Asuragen will develop, also for Digene's exclusive distribution, the next generation CF test, Signature CF Expand, which expands the mutation panel to include ethnic-specific mutations that can be adapted for use in carrier screening and may find additional utility for neonatal and newborn testing. In addition, Digene will have the first right of refusal on future genetic test products developed by Asuragen. The Signature products utilize the Luminex xMAP technology.

Evan Jones, Chairman and CEO of Digene commented, "Underscoring Digene's commitment to women's health, we are pleased to offer this important genetic screening product. Through this collaboration, Digene will leverage its strong physician and reference lab sales forces to market and distribute CF products that are developed and manufactured by Asuragen, a leader in the development of innovative nucleic acid products. This agreement will allow Digene to offer its customers reliable and easy-to-use solutions for carrier screening, thus enabling enhanced patient care through better informed decisions."

Cystic Fibrosis is the most common autosomal recessive disease in the Caucasian population with a prevalence estimate of 1 in 2,500 to 3,300 live births.